Comparative study of immune response and safety of booster immunisation with two tetanus vaccines (Vacteta and Tetavax) in health adults.

Phase 1

• Conditions: Verification of immune response after booster immunisation with one dose of tetanus monovalent vaccine; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-004934-11-CZ
• Lead Sponsor: BIODRUG s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-24
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects must have signed an approved informed consent after complete information
2. Subjects must have written confirmation on previous immunisation against tetanus not older than 15.9 years and not younger than 9.9 years
3. Men and women aged 24.1- 64.9 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject without written confirmation of previous vaccination against tetanus, no older than 15.9 years, and not younger than 9.9 years.
2. Subject with acute infectious diseases.
3. Subjects under 24 years of age or older than 65 years, inclusive.
4. Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial (i.e., test and comparator tetanus vaccine).
5. Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus.
6. Pregnant woman and breastfeeding (anamnestically).
7. Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukaemia, lymphoma, Hodgkin's disease, multiple myeloma, generalised malignancy, drugs or other causes induced imunodefiency).
8. Subject with progressive or unstable neurological disorder.
9. Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular use.
10. Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
11. Subject vaccinated less than 30 days inactivated or live vaccine prior to study entry.
12. Participants, who may become pregnant and will take at least a reliable method of contraception during the trial and until its completion.
Reliable contraceptive method (ie. methods that can achieve a failure rate of less than 1% per year), reliable contraceptive methods are: progestogen only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide. Participants may also use contraceptive methods with a low failure rate, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence (if it corresponds with the preferred and usual lifestyle of participants - but periodic abstinence [eg. by calendar or ovulation], and intermittent contact methods are not acceptable contraceptive methods), bilateral tubal occlusion or partner who had a vasectomy with documented aspermia.
13. Subject incapable of cooperation, incompetent.
14. Subject addicted to alcohol, drugs.
15. Subject unwilling to sign an informed consent.
16. Subject currently participating in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
17. Dependents (eg soldiers, persons dependent on the researcher - such as subordinates, family members).
18. Subject requiring vaccination against tetanus after injury.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of immunogenicity of tetanus monovalent vaccine Vacteta after booster immunisation of health adults compared with that induced by vaccine Tetavax.;Secondary Objective: Evaluation of safety after booster immunisation with tetanus monovalent vaccine Vacteta. ;Primary end point(s): The primary measurement is the concentration of antibodies specific against tetanus. The primary endpoint will be seroconversion, ie. the proportion of subjects complying the positive criteria of seroconversion. The seroconversion rules are defined as followed: for pre-vaccination levels =0.1 IU/ml the post-vaccination levels must increase at least 4-fold and must be higher than 0.4 IU/ml; for prevaccination levels higher than 0.1 IU/ml the post-vaccination levels must increase at least 4-fold.;Timepoint(s) of evaluation of this end point: Before vaccine administration at the same day (V1) and 28 days after vaccine administration (V2).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are the geometric mean of antibodies specific against tetanus and proportions of adverse events.;Timepoint(s) of evaluation of this end point: Before vaccine administration at the same day (V1) and 28 days after vaccine administration (V2). Adverse event will be monitored within 30 minutes and within the following 28 days after immunisation.